The Role:This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliverables across Moderna's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patientsHere's What You'll Do:Support study lead programmer to oversee CRO all programming deliverables and milestones from study start-up to study completion, maintaining programming standards and ensuring compliance with SOPs to produce high quality and timely deliverablesServe as a study programming team member and work closely with study lead programmer in all aspects of the development of the Statistical Programming deliverablesParticipate in the review of CRFs and CRF Completion GuideParticipate in the review of SAP and ShellsParticipate in the review of SDTM annotation CRF, SDTM and ADaM specificationsDevelop QC Programs independently to support internal QC for key elementsDevelop programs to support ad-hoc requests-based analysis with no or minimal supervisorCollaborate closely with Study leads, Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Moderna to effectively address their needs for programming support.Participate in the development of CRFs, edit check specifications, and data validation plansCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goalsOversee statistical programming contractors and mentor junior team membersHere's What You'll Bring to the Table:MS or PhD (or equivalent degree) with 3+ years or BS with 5+ years of relevant work experience in Biotech, Pharma, Clinical Research Organizations, or other relevant organizationsMastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPHKnowledge of relevant FDA, EU, ICH guidelines and regulations.Experience working with CROs, vendors, and relationship management preferred.Outstanding communication skills (verbal and written).Ability to manage multiple projects in a fast-paced environment.Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) #LI-KF1-
